Spectrophotometric Estimation and Validation of Canagliflozin and Metformin Hydrochloride in Binary Mixture

Abstract

The purpose of the work was to establish a UV spectroscopic method for the simultaneous estimation of canagliflozin and metformin hydrochloride in a binary mix. This method involves interpretation of simultaneous equations based on measurement of absorbance at two wavelengths, 237 nm and 290 nm, using UV-visible spectrophotometer with 1cm matched quartz cells. Methanol solvent was employed in this method. The developed method obeyed Beer’s-Lambert’s law in the concentration range of 2-12 µg/mL, having correlation coefficient 0.9998 and 0.9994 for canagliflozin and metformin hydrochloride, respectively. Different validation parameters like accuracy, precision, limit of detection and limit of quantitation were examined and found to be within the limits. The results of the method were validated as per ICH guidelines. A novel, simple, sensitive, rapid, accurate and economical spectrophotometric methods have been developed for simultaneous estimation of canagliflozin and metformin HCl. The technique can be used to determine the amount of canagliflozin and metformin HCl in a mixture containing canagliflozin and metformin. The absorptivities of canagliflozin and metformin HCl are 0.0481 and 0.0921, respectively. Sandell’s sensitivity (mg/cm2 /0.001 absorbance unit) for canagliflozin and metformin HCl was found to be 0.025 and 0.02931, respectively.